2018年是推进医疗器械审评审批制度改革落地之年。国家药品监督管理局医疗器械技术审评中心认真贯彻党中央、国务院以及国家市场监督管理总局、国家药品监督管理局各项决策部署要求,围绕保障公众用械安全有效使命,以科学审评、风险管控为基本理念,以提升医疗器械审评质量和效率为目标,优化和再造审评流程、完善鼓励创新措施、畅通对外沟通交流渠道、提升审评队伍能力素质,医疗器械技术审评工作再上新台阶。
<<2018 is the year of reforms for advancing the medical device review and approval system. In the past year,the Center for Medical Device Evaluation of NMPA had meticulously implemented the decisions and arrangements of the CPC Central Committee,the State Council,the State Administration for Market Regulation,and the National Medical Products Administration. Our Mission focused on safeguarding the public utilization of medical devices using scientific evaluation and risk management as basic principles. Our Goals are to optimize and streamline the quality and effectiveness of medical device pre-market review process;thereby promoting the initiatives of review system innovation,the optimization of communication channels,the quality of the review teams so as to push the works of medical device pre-market reviews to greater heights.
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